Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial … (NCT05104099) | Clinical Trial Compass
CompletedPhase 2
Evaluation of New Diagnostic Tool Using Fluorescence to Detect High-grade Vulvar Intraepithelial Neoplasia
France17 participantsStarted 2021-11-29
Plain-language summary
This study is a single-center propsective clinical trial to assess the ability of fluorescence techniques to mark high-grade vulvar intraepithelial neoplasias including high-grade vulvar squamous intraepithelial lesions and differentiated vulvar intraepithelial neoplasias following 3 hours Metvixia application.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient aged 18 and over,
* With isolated high-grade vulvar intraepithelial neoplasia OR associated with invasive cancer proven histologically by biopsy
* Naive of any vulvovaginal treatment (surgery or radiotherapy)
* No metastases
* WHO \<or equal to 3
* Contraception method for women of childbearing potential
* Patient affiliated to the social security scheme
* Patient who understood, signed and dated the information note and the
* consent form,
* Patient able and willing to follow all study procedures in accordance with the protocol.
Exclusion Criteria:
* History of hypersensitivity to the active substance methyl aminolevulinate or to any of the components of the drug (including peanut oil and refined almond oil), soybean or peanut
* Ulceration or hyperpigmented lesions of the vulva
* Patient with porphyria
* Any previous vulvovaginal treatment (surgery or radiotherapy)
* Metastatic disease
* Patient undergoing treatment for any other invasive cancer
* Pregnant, likely to be or breastfeeding patient
* Patient deprived of liberty or under guardianship (including guardianship)
* Inability to undergo medical monitoring of the trial for geographic, social or psychological reasons.
* Patient already included in another therapeutic trial with an experimental molecule,
* Associated pathology that may prevent the patient from receiving METVIXIA application and light exposure.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of the success of the photodynamic diagnosis
Timeframe: 14 days (+/- 4 days) after the photodiagnosis